TPLC - Total Product Life Cycle

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Device	catheter, oximeter, fiber-optic
Product Code	DQE
Regulation Number	870.1230
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	121	121
Material Rupture	76	76
Leak/Splash	50	50
Incorrect Measurement	44	44
Appropriate Term/Code Not Available	34	34
Adverse Event Without Identified Device or Use Problem	33	33
Fluid/Blood Leak	20	20
Device Contamination with Chemical or Other Material	19	19
Deflation Problem	17	17
Unable to Obtain Readings	13	13
Material Split, Cut or Torn	12	12
Inflation Problem	12	12
Difficult to Insert	12	12
Material Separation	11	11
Break	9	9
Output Problem	9	9
Material Fragmentation	8	8
Kinked	7	7
Detachment Of Device Component	6	6
Detachment of Device or Device Component	6	6
Device Operates Differently Than Expected	6	6
Difficult to Remove	5	5
Material Puncture/Hole	5	5
Positioning Problem	5	5
Physical Resistance/Sticking	4	4
Difficult to Advance	4	4
Low Readings	3	3
Malposition of Device	3	3
Crack	3	3
No Device Output	3	3
Connection Problem	2	2
Material Protrusion/Extrusion	2	2
Display or Visual Feedback Problem	2	2
Insufficient Flow or Under Infusion	2	2
Device Displays Incorrect Message	2	2
High Test Results	2	2
Material Twisted/Bent	2	2
Obstruction of Flow	2	2
Difficult or Delayed Positioning	2	2
Temperature Problem	2	2
Component Missing	2	2
Contamination /Decontamination Problem	2	2
Microbial Contamination of Device	2	2
Burst Container or Vessel	2	2
Torn Material	2	2
Device Alarm System	2	2
Failure to Advance	2	2
Increase in Pressure	2	2
Insufficient Information	2	2
Unintended Movement	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	265	265
No Clinical Signs, Symptoms or Conditions	134	134
No Known Impact Or Consequence To Patient	76	76
Hemorrhage/Bleeding	13	13
Insufficient Information	11	11
No Code Available	9	9
No Patient Involvement	8	8
No Information	8	8
Cardiac Perforation	7	7
Blood Loss	6	6
Low Blood Pressure/ Hypotension	6	6
Perforation of Vessels	5	5
Hypersensitivity/Allergic reaction	4	4
Perforation	4	4
Cardiac Arrest	4	4
Foreign Body In Patient	4	4
Arrhythmia	3	3
Unspecified Infection	3	4
Shaking/Tremors	3	3
Congenital Defect/Deformity	3	3
Respiratory Distress	2	2
Pneumothorax	2	2
Hemothorax	2	2
Hematoma	2	2
Death	2	2
Thrombus	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Fever	2	2
Chills	2	2
Injury	2	2
Patient Problem/Medical Problem	2	2
Aneurysm	2	2
Aortic Valve Stenosis	1	1
Mitral Valve Stenosis	1	1
Infiltration into Tissue	1	1
Ectopic Heartbeat	1	1
Tricuspid Regurgitation	1	1
Embolism	1	1
Swelling/ Edema	1	1
Respiratory Failure	1	1
Stenosis	1	1
Device Embedded In Tissue or Plaque	1	1
Tachycardia	1	1
Reaction	1	1
Pneumonia	1	1
Dyspnea	1	1
Therapy/non-surgical treatment/delayed/prolonged	1	1
Thrombosis	1	1
Needle Stick/Puncture	1	1
Ventricular Fibrillation	1	1